Dossier Submission – Which Trials To Include?

MHRA CTU Inspections

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    Hi all,

    When compiling the list of CTIMPs required as part of the pre-inspection dossier submission, does anyone apply any exclusions (e.g. stem cell trials, or trials that haven’t recruited any UK subjects), or do you simply list all CTIMPs?

    Thanks,

    Jennifer

     

    Jennifer MacPhee
    Quality Manager
    Robertson Centre for Biostatistics
    University of Glasgow
    Tel: 0141 330 3122
    http://www.gla.ac.uk/researchinstitutes/healthwellbeing/research/robertsoncentreforbiostatistics/
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